Comparison · NCT02558231-sae
Triple Oral Therapy (Macitentan, Tadalafil, and Selexipag) vs Double Oral Therapy (Macitentan, Tadalafil, and Placebo): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Triple Oral Therapy (Macitentan, Tadalafil, and Selexipag) vs Double Oral Therapy (Macitentan, Tadalafil, and Placebo): serious adverse events. Trial comparisons, record NCT02558231-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02558231-sae
On this page
Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.487 | 0.399 | 0.576 | wilson | |
| Risk in group 2 | 0.378 | 0.298 | 0.465 | wilson | |
| Risk difference, group 1 minus group 2 | 0.109 | -0.0141 | 0.229 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.29 | 0.966 | 1.72 | log | |
| Odds ratio, group 1 over group 2 | 1.56 | 0.942 | 2.6 | log | |
Number needed to harm, for one more participant with a serious adverse event on Triple Oral Therapy (Macitentan, Tadalafil, and Selexipag) than on Double Oral Therapy (Macitentan, Tadalafil, and Placebo) | 9.14 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Triple Oral Therapy (Macitentan, Tadalafil, and Selexipag) | Participants received macitentan oral tablet, 10 milligrams (mg) once daily and tadalafil oral tablet, 20 mg, once daily from Day 1 up to End of treatment (10 months after last participant was enrolled). Tadalafil was up-titrated from 20 mg to 40 mg on Day 8. In addition, participants received selexipag oral tablet at a starting dose of 200 micrograms (mcg), twice daily from Day 15 up-titrated to a maximum of 1600 mcg, up to End of treatment (10 months after last participant was enrolled). | 58 | 119 | EG000 |
| Group 2 | Double Oral Therapy (Macitentan, Tadalafil, and Placebo) | Participants received macitentan oral tablet, 10 mg once daily and tadalafil oral tablet, 20 once daily from Day 1 up to End of treatment (10 months after last participant was enrolled). Tadalafil was up-titrated from 20 mg to 40 mg on Day 8. In addition, participants received placebo matching to selexipag oral tablet, at a starting dose of 200 micrograms (mcg), twice daily from Day 15 and dose up-titrated to a maximum of 1600 mcg, up to End of treatment (10 months after last participant was enrolled). | 48 | 127 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 42 Months
Source ClinicalTrials.gov
Trial
- Title
- The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension
- NCT number
- NCT02558231
- Phases
- PHASE3
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Macitentan, Tadalafil, Selexipag
- Lead sponsor
- Actelion
- Results first posted
- 2020-09-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02558231?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02558231-sae